- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04883502
Study of the Role of the Induced Membrane in the Reconstruction of Bone Loss in the Limbs (MEMBRAN)
Masquelet's induced membrane technique is a two-stage reconstructive surgery for severe bone fractures commonly used by military orthopedists. The particularity of this technique relies on the synthesis of a biological membrane induced by the transient implantation of a surgical cement (= 1st stage surgery). The presence of the induced membrane in the reconstruction space defines a microenvironment or "biological chamber" favourable to osteogenesis, positively influencing the repair of the lesion after implantation of an autologous bone graft (= 2nd stage of surgery).
In view of the excellent clinical results obtained with this procedure, the Masquelet technique has gradually become a reference treatment in the field of orthopedic and trauma surgery.
However, orthopedic surgeons sometimes observe failures in bone consolidation. To our knowledge, the role played by induced membrane in these therapeutic failures has never been studied.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Marjorie DURAND, PhD
- Phone Number: +33 178651146
- Email: marjorie1.durand@intradef.gouv.fr
Study Contact Backup
- Name: Laurent MATHIEU, MD, PhD
- Phone Number: +33 141466157
- Email: laurent-m2.mathieu@intradef.gouv.fr
Study Locations
-
-
-
Clamart, France, 92140
- Recruiting
- Hôpital d'Instruction des Armées PERCY
-
Contact:
- Laurent MATHIEU, MD, PhD
- Phone Number: +33 141466157
- Email: laurent-m2.mathieu@intradef.gouv.fr
-
Saint-Mandé, France, 94160
- Recruiting
- Hôpital d'Instruction des Armées Begin
-
Contact:
- Thomas DEMOURES, MD
- Phone Number: +33 140514103
- Email: thomas.demoures@intradef.gouv.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥ 18 years
- Patient with traumatic bone loss
- Patient eligible for the induced membrane technique
Exclusion Criteria:
- Patients with post-tumor bone loss
- Patients who are immunocompromised or under immunosuppressive treatment
- Patients with chronic inflammatory disease (diabetes, inflammatory bowel disease)
- Patients with collagenosis
- Patient with a contraindication to sampling
- Pregnant or breastfeeding women
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Histological profile of induced membrane fragments
Time Frame: Through study completion, an average of 6,5 years
|
Presence of abnormalities in the organization of connective fibers.
The profile of induced membrane fragments will be compared between patients who respond and patients who do not respond to the induced membrane technique.
|
Through study completion, an average of 6,5 years
|
Cellular profile of induced membrane fragments
Time Frame: Through study completion, an average of 6,5 years
|
Presence of mesenchymal stromal cells, ability of these cells to differentiate into osteoblasts, presence of other cell types (such as adipocytes and osteoclasts). The profile of induced membrane fragments will be compared between patients who respond and patients who do not respond to the induced membrane technique. |
Through study completion, an average of 6,5 years
|
Secretory profile of induced membrane fragments
Time Frame: Through study completion, an average of 6,5 years
|
Determination of proteins secreted by the induced membrane fragments by mass spectrometry or by enzyme-linked immunosorbent assay. The profile of induced membrane fragments will be compared between patients who respond and patients who do not respond to the induced membrane technique. |
Through study completion, an average of 6,5 years
|
Gene expression profile of induced membrane fragments
Time Frame: Through study completion, an average of 6,5 years
|
Expression of several genes of interest related to angiogenesis, mesenchymal stromal cells mobilization, bone formation or resorption and extracellular matrix remodeling. The profile of induced membrane fragments will be compared between patients who respond and patients who do not respond to the induced membrane technique. |
Through study completion, an average of 6,5 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019PPRC03
- 2021-A00561-40 (Other Identifier: IDRCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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